The Stryker Navigation System, when used with the SpineMap Go software application, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a rigid anatomical structure such as the pelvis, skull, or spine can be identified. The system assists in the positioning of instruments for procedures on the spine and pelvis, including the following procedures: Screw Placement in the spine and pelvis, Needle Placement in the spine and pelvis.

The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker Spine Navigation Systems. It is placed onto the patient's skin dorsal to the spine. In combination with intraoperative imaging devices, it enables automatic patient registration for open or percutaneous computer assisted surgery. When used for patient tracking, the Stryker SpineMaskTM Tracker supports minimally invasive procedures on the lumbar and thoracic spine.

The Fluoroscopy Adapters and Fluoroscopy Trackers are intended to be used as accessories to the Stryker Navigation System. The Fluoroscopy Tracker is connected to the Fluoroscopy Adapter which is attached to the C-arm fluoroscopy system. The Fluoroscopy Tracker transmits signals that are used by the Stryker Navigation System to calculate the spatial relationship between the C-arm and the patient. The Fluoroscopy Adapter and Fluoroscopy Tracker may be used as part of the Stryker Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

Device Description

The Stryker Navigation System with the SpineMap Go software application is intended for use as an image guided surgery system to enable open or percutaneous computer assisted spinal surgery. It assists the surgeon in positioning of instrumentation during spinal surgeries. The system provides intraoperative guidance to the surgeon using augmented fluoroscopy. Wireless optical tracking technology is used to estimate the position of navigated surgical instruments and displaying their position on medical fluoroscopic images from mobile C-arm. The Stryker Navigation System with SpineMap Go software is comprised of a platform, SpineMap Go software, navigated instruments (e.g. patient/instrument trackers, pointers), and accessories. The system uses wireless optical tracking technology to display the intraoperative location of navigated surgical instruments relative to mobile C-arm fluoroscopy images. The platform consists of a computer, camera, monitor and IO (input/output) Tablet. The SpineMap Go software is dedicated for spinal procedures as defined in the Indications for Use. Required navigated instruments include instruments such as a patient tracker, an instrument tracker, and pointers. An instrument battery is also required when a battery powered navigated instrument or calibration device is used.

The SpineMap Go software application is a required part of the Stryker Navigation System. It is installed by a Stryker representative on the platform. The SpineMap Go software application is used on a platform and interfaces with Stryker navigated instruments and accessories. It is compatible with the Nav3i Platform family, which includes the NAV3i. NAV3. and NavSuite3. SpineMap Go is an interactive software application that provides the functions necessary to conduct the indicated spinal procedures. The software application implements methods for image adjustment, image registration, and instrument navigation. The SpineMap Go Software Application provides new features including the integration of the SpineMask Tracker and the complete Stryker navigation enabled spine instrument portfolio, an updated Image Acquisition component for 2D C-arm support, support for existing C-arm Fluoroscopy Trackers, an updated user interface for improved usability, an updated software architecture, and improved cybersecurity aspects.

The SpineMask Tracker is a sterile, single use device. It is intended to be used as an accessory to the Stryker Spine Navigation Systems which include the SpineMap 3D and SpineMap Go software applications. It is a flexible, patient tracker that is attached to a patient's skin and provides non-invasive patient tracking of the thoracic and lumbar spine. It is applied to the skin, dorsal to the patient's spine, via an integrated adhesive tape. The SpineMask Tracker includes infrared LED's that are positioned on the flexible portion of the device. The LED positions are measured by the navigation system after the SpineMask Tracker is applied to the patient's back. Upon activation of the SpineMask Tracker, the LED positions are measured (i.e., captured) by the navigation system. While being tracked, the LED positions are measured and compared to their initial positions as determined during the capturing step. The software is able to detect whether the flexible SpineMask Tracker is deformed when the position of the corresponding LED pairs differ significantly. If this difference is beyond a specific threshold, the LEDs are not used for patient tracking.

The Fluoroscopy Trackers and the Fluoroscopy Adapters serve to connect a C-arm with the Stryker navigation system. The Fluoroscopy Adapter is mounted onto the C-arm image intensifier to interface with the Fluoroscopy Tracker. The Fluoroscopy Tracker transmits signals that are received by the navigation camera. The navigation system uses the signals to calculate the spatial relationship between the C-arm and the patient. The position of the C-arm, relative to the patient's anatomy, is displayed on the navigation system monitor. The radiopaque fluoroscopy markers within the Fluoroscopy Phantom on the tracker are used to correct the image distortion caused by the image intensifier sensor technology and to compute the geometry of the C-arm. The computed geometry of the C-arm is defined by the position of the focal point relative to the image sensor. The position of the focal point varies based on the C-arm position and gravity deforming the C-arm. The focal point is used later to compute the correct projection of the 3D tool onto the 2D fluoroscopy image.

AI/ML Overview

The provided text contains information about the Stryker Navigation System with SpineMap Go Software Application, SpineMask Tracker, and Fluoroscopy Trackers and Fluoroscopy Adapters. However, it does not describe a study involving an AI/Machine Learning component with specific acceptance criteria related to accuracy metrics like precision, recall, or F1 score, or human reader performance.

The document primarily focuses on:

Regulatory Clearance (510(k)): It's a submission for premarket notification, demonstrating substantial equivalence to predicate devices.
Device Description: Explains the components and how they function for surgical navigation.
Intended Use: Specifies the medical conditions and procedures for which the devices are indicated.
Technological Comparison: Compares the subject devices with their predicate devices, particularly highlighting updates to software and adherence to new IEC standards for safety.
Non-Clinical Testing: Summarizes various engineering and validation tests (intended use/user needs, accuracy, safety, general requirements, software, electrical safety, electromagnetic compatibility).
Clinical Testing: Explicitly states "No clinical testing was performed."

Therefore, I cannot fulfill most of the requested points as they pertain to AI/ML study design and evaluation metrics which are not present in this document.

However, I can extract the acceptance criteria and reported performance for the system accuracy as described in the non-clinical testing section.

Here's what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Metric	Acceptance Criteria	Reported Device Performance
System Accuracy	Mean accuracy of 2 mm point and 2º angular axis displacement within the registration zone.	Positional displacement (mm): Median 0.54, Interquartile Range 0.85, 99th Percentile 2.17, Mean 0.68, Standard Deviation 0.59, 99th Confidence Interval Upper Bound 2.14. Trajectory Angle Displacement (Degrees): Median 0.51, Interquartile Range 0.50, 99th Percentile 2.09, Mean 0.56, Standard Deviation 0.37, 99th Confidence Interval Upper Bound 1.52.
(95th percentile)	The 95th percentile of the point displacement is ≤3 mm and ≤3° for angular axis displacement.	Implicitly met by reported 99th percentiles (2.17 mm and 2.09 degrees), which are below the 3mm and 3 degree threshold for 95th percentile.

Note: The reported performance metrics (median, interquartile range, 99th percentile, mean, standard deviation, 99th Confidence interval upper bound) provide more detailed information than just the mean, strongly indicating the device meets the specified accuracy criteria.

The following information CANNOT be extracted or is explicitly stated as N/A from the provided document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified. The "Intended Use/User Needs" testing used "cadaver labs or simulated use tests," but no sample sizes or data provenance are detailed for the accuracy testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as this is a navigation system with physical accuracy measurements, not an image interpretation AI/ML device relying on expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable (not an AI/ML image interpretation study).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The document explicitly states "No clinical testing was performed," and this device does not involve AI assistance for human image readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The accuracy metrics provided are for the system itself, which can be seen as the "standalone" performance in terms of its navigational accuracy. However, this is for a surgical navigation system, not an AI algorithm performing diagnostic tasks.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the system accuracy, the ground truth would be precise, objective measurements from controlled laboratory settings, likely using fiducial markers or calibrated measurement tools. It's an engineering ground truth, not a medical classification ground truth.
The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set in the conventional sense. The "software" testing mentioned focuses on verification and validation against IEC standards and FDA guidance, not model training.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below it.

February 14, 2019

Stryker Corporation Andrea Wallen-Gerding Principal Regulatory Affairs Specialist Bötzinger Straße 41 Freiburg, D-79111 DE

Re: K183196

Trade/Device Name: Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 16, 2018 Received: November 19, 2018

Dear Andrea Wallen-Gerding:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jesse Muir-S

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183196

Device Name

Fluoroscopy Adapters and Fluoroscopy Trackers

Indications for Use (Describe)

The Fluoroscopy Adapter and Fluoroscopy Tracker may be used as part of the Stryker Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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Indications for Use

510(k) Number (if known) K183196

Device Name

Stryker Navigation System with SpineMap Go software application

Indications for Use (Describe)

The system is indicated for any medical condition in which computer assisted planning and surgery may be appropriate. The system can be used for intraoperative quidance where a rigid anatomical structure such as the pelvis, skull, or spine can be identified.

The system assists in the positioning of instruments for procedures on the spine and pelvis, including the following procedures:

Screw Placement in the spine and pelvis
Needle Placement in the spine and pelvis

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K183196

Device Name SpineMask Tracker

Indications for Use (Describe)

The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker Spine Navigation Systems. It is placed onto the patient's skin dorsal to the spine.

· In combination with intraoperative imaging devices, it enables patient registration for open or percutaneous computer assisted surgery.

· When used for patient tracking, the Stryker SpineMask™ Tracker supports minimally invasive procedures on the lumbar and thoracic spine.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Submitter Information 6.0

This Premarket Notification is submitted by: 6.1

Stryker Leibinger GmbH & Co. KG

Bötzinger Straße 41

79111 Freiburg, Germany

6.2 Contact Information

Contact Name: Andrea N. Wallen-Gerding Office Telephone: (269) 389-2884 Fax: (269) 389-5412 Email: andrea.wallengerding@stryker.com Date Prepared: November 16, 2018

Device Name 6.3

Table 6-1: Device Name

Subject (Modified) Device Information
Trade/ Proprietary Name	Stryker Navigation System with SpineMap Go softwareapplication, SpineMask Tracker, Fluoroscopy Adapters,Fluoroscopy Trackers
Common Name	Spine Navigation System, Fluoroscopy Adapters,Fluoroscopy Trackers, SpineMask Tracker
Classification	Class II
Classification Product Code	OLO
Classification Name	Orthopedic Stereotaxic Instrument
Classification Regulation	21 CFR 882.4560
Review Panel	Orthopedic

Predicate Devices 6.4

The following are the legally marketed predicate devices for the subject devices included in this Traditional 510(k):

Subject Device	Predicate Device Trade Name	510(k)	Predicate DeviceProduct Code
Stryker Navigation Systemwith the SpineMap GoSoftware Application	Stryker Navigation System - Spineand Fluoroscopy System withFluoroscopy 2.3 Software	K012380	HAW
SpineMask Tracker	SpineMask Tracker	K141941	OLO
Fluoroscopy Adapter (PhilipsBV300, 9")	Fluoroscopy Adapter (PhilipsBV300, 9")	K012380	HAW

Table 6-2: Predicate Device List

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Subject Device	Predicate Device Trade Name	510(k)	Predicate DeviceProduct Code
Fluoroscopy Adapter (OEC9800, 9")	Fluoroscopy Adapter (OEC 9800,9")	K012380	HAW
Fluoroscopy Adapter (ZiehmExposcope, 9")	Fluoroscopy Adapter (ZiehmExposcope, 9")	K012380	HAW
Fluoroscopy Adapter (SiemensISO-C, 9")	Fluoroscopy Adapter (SiemensISO-C, 9")	K012380	HAW
Fluoroscopy Adapter (PhilipsBV300, 12")	Fluoroscopy Adapter (PhilipsBV300, 12")	K012380	HAW
Fluoroscopy Adapter (OEC,12")	Fluoroscopy Adapter (OEC, 12")	K012380	HAW
Fluoroscopy 3D Kit (SiemensISO-C, 9")	Fluoroscopy 3D kit (Siemens ISO-C, 9")	K012380	HAW
Fluoroscopy 3D Adapter(Siemens ISO-C, 9")	Fluoroscopy 3D Adapter (SiemensISO-C, 9")	K012380	HAW
3D Installation Set (SiemensISO-C)	3D Installation Set (Siemens ISO-C)	K012380	HAW
Fluoroscopy Tracker Kit, 9"	Fluoroscopy Tracker Kit, 9"	K012380	HAW
Fluoroscopy Tracker Kit, 12"	Fluoroscopy Tracker Kit, 12"	K012380	HAW

6.5 Device Descriptions

6.5.1 Stryker Navigation System with the SpineMap Go™ Software Application Overview

The Stryker Navigation System with SpineMap Go software is comprised of a platform, SpineMap Go software, navigated instruments (e.g. patient/instrument trackers, pointers), and accessories. The system uses wireless optical tracking technology to display the intraoperative location of navigated surgical instruments relative to mobile C-arm fluoroscopy images. The platform consists of a computer, camera, monitor and IO (input/output) Tablet. The SpineMap Go software is dedicated for spinal procedures as defined in the Indications for Use. Required navigated instruments include instruments such as a patient tracker, an instrument tracker, and pointers. An instrument battery is also required when a battery powered navigated instrument or calibration device is used.

6.5.1.1 SpineMap GoTM Software Application

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Nav3i Platform family, which includes the NAV3i. NAV3. and NavSuite3.

SpineMap Go is an interactive software application that provides the functions necessary to conduct the indicated spinal procedures. The software application implements methods for image adjustment, image registration, and instrument navigation.

The SpineMap Go Software Application provides new features including the integration of the SpineMask Tracker and the complete Stryker navigation enabled spine instrument portfolio, an updated Image Acquisition component for 2D C-arm support, support for existing C-arm Fluoroscopy Trackers, an updated user interface for improved usability, an updated software architecture, and improved cybersecurity aspects.

6.5.2 SpineMask Tracker

The SpineMask Tracker is a sterile, single use device. It is intended to be used as an accessory to the Stryker Spine Navigation Systems which include the SpineMap 3D and SpineMap Go software applications. (The SpineMask Tracker is currently included as an accessory to the SpineMap 3D 3.1 software application which was cleared per 510(k) K172034.)

The SpineMask Tracker is a flexible, patient tracker that is attached to a patient's skin and provides non-invasive patient tracking of the thoracic and lumbar spine. It is applied to the skin, dorsal to the patient's spine, via an integrated adhesive tape.

The SpineMask Tracker includes infrared LED's that are positioned on the flexible portion of the device. The LED positions are measured by the navigation system after the SpineMask Tracker is applied to the patient's back. Upon activation of the SpineMask Tracker, the LED positions are measured (i.e., captured) by the navigation system. While being tracked, the LED positions are measured and compared to their initial positions as determined during the capturing step. The software is able to detect whether the flexible SpineMask Tracker is deformed when the position of the corresponding LED pairs differ significantly. If this difference is beyond a specific threshold, the LEDs are not used for patient tracking.

6.5.3 Fluoroscopy Trackers and Fluoroscopy Adapters

The radiopaque fluoroscopy markers within the Fluoroscopy Phantom on the tracker are used to correct the image distortion caused by the image intensifier sensor technology and to compute the geometry of the C-arm. The computed geometry of the C-arm is defined by the position of the focal

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point relative to the image sensor. The position of the focal point varies based on the C-arm position and gravity deforming the C-arm. The focal point is used later to compute the correct projection of the 3D tool onto the 2D fluoroscopy image.

6.6 Indications for Use

6.6.1 Stryker Navigation System with the SpineMap Go Software Application

The system is indicated for any medical condition in which computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as the pelvis, skull, or spine can be identified.

The system assists in the positioning of instruments for procedures on the spine and pelvis, including the following procedures:

Screw Placement in the spine and pelvis
Needle Placement in the spine and pelvis

6.6.2 SpineMask Tracker

6.6.3 Fluoroscopy Adapters and Fluoroscopy Trackers

6.7 Comparison of Technological Characteristics

A comparison of the technological characteristics of the subject devices included in the scope of this Traditional 510(k) is included in the tables below.

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6.7.1 Technological Comparison between the Stryker Navigation System with SpineMap Go Software and the Stryker Navigation System - Spine and Fluoroscopy System with Fluoroscopy 2.3 Software
The technological comparison between the subject device, Stryker Navigation System with SpineMap Go software application and the predicate device (Stryker Navigation System - Spine and Fluoroscopy System with Fluoroscopy 2.3 Software) is included in Table 6-3 below. The system accuracy for both the predicate and subject devices are based on non-clinical test data.

Table 6-3: Technological Comparison between Stryker Navigation System with SpineMap Go software application (Subject Device) and the Predicate Device

Item	Subject Device:Stryker Navigation System with SpineMap GoSoftware Application	Predicate Device:Stryker Navigation System – Spine andFluoroscopy System with Fluoroscopy 2.3Software (K012380)
Indicationsfor Use	The Stryker Navigation System, when used withthe SpineMap Go software application, is intendedas a planning and intraoperative guidance systemto enable open or percutaneous computer assistedsurgery.The system is indicated for any medical conditionin which computer assisted planning and surgerymay be appropriate. The system can be used forintraoperative guidance where a reference to arigid anatomical structure such as the pelvis, skull,or spine can be identified.The system assists in the positioning ofinstruments for procedures on the spine and pelvis,including the following procedures:• Screw Placement in the spine and pelvis• Needle Placement in the spine and pelvis	The Stryker Navigation System is intendedas a planning and intraoperative guidancesystem to enable open or percutaneous imageguided surgery. The system is indicated forany medical condition in which the use ofimage guided surgery may be appropriate,and where a reference to a rigid anatomicalstructure such as the skull, or vertebra can beidentified relative to medical images.The Stryker Navigation System – Spine &Fluoroscopy Module supports, but is notlimited to the following surgical procedures:• Pedicle Screw Placement• Navigation• Precisely positioning instruments orimplants during orthopedic surgery,such as operations performed withspinal structure, hip and bones in theupper and lower extremities and longbones.
Main SystemComponents	• Platform• SpineMap Go Software Application• Navigated Instruments• Accessories	• Platform• Fluoroscopy 2.3 Software Application• Navigated Instruments• Accessories
Modes ofOperation	• Patient Preparation• System Set-up• Image Registration• Navigation	• Patient Preparation• System Set-up• Image Registration• Navigation
Localizingand TrackingTechnology	Infrared optical active sensing technology:Infrared light emitted by diodes placed in specificlocations on navigated surgical instruments issensed by a camera array (navigation camera) onthe platform, which allows for computation of thespatial information	Infrared optical active sensing technology:Infrared light emitted by diodes placed inspecific locations on navigated surgicalinstruments is sensed by a camera array(navigation camera) on the platform, whichallows for computation of the spatialinformation
OperatingPrinciple	• The software is installed on the computer that ispart of the platform	• The software is installed on the computerthat is part of the platform

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Item	Subject Device:Stryker Navigation System with SpineMap GoSoftware Application	Predicate Device:Stryker Navigation System – Spine andFluoroscopy System with Fluoroscopy 2.3Software (K012380)
	• Images are imported in DICOM (Siemens C-arm with proprietary NaviLink 2D protocol) or analog video connection• The software displays the images with navigational information on a monitor	• Images are imported in DICOM (Siemens C-arm with proprietary NaviLink 2D protocol) or analog video connection• The software displays the images and planned items with navigational information on a monitor
SystemAccuracy	The system is designed to work in the working space with a mean accuracy of 2 mm point and 2º angular axis displacement within the registration zoneThe 95th percentile of the point displacement is ≤3 mm and ≤3° for angular axis displacement.	Mean navigation accuracy of ± 2mm point (tip) displacement and ± 2° angular axis displacement.
	Positionaldisplacement(mm) TrajectoryAngleDisplacement(Degrees) Median 0.54 0.51 InterquartileRange 0.85 0.50 99thPercentile 2.17 2.09 Mean 0.68 0.56 StandardDeviation 0.59 0.37 99thConfidenceIntervalUpperBound 2.14 1.52
SupportedImagingModalities	• C-arm with image intensifier	• C-arm with image intensifier
RegistrationFeatures	• Image Registration	• Image Registration
EnergySource	• Main Power: Alternating Current (AC) power supply, 100/240 V and 50/60 Hz• Off-the-Shelf uninterruptable power supply for power interruptions ≤ 6 minutes	• Main Power: Alternating Current (AC) power supply, 100/240 V and 50/60 Hz• Off-the-Shelf uninterruptable power supply for power interruptions ≤ 6 minutes
Intended UseEnvironment	Operating Room (OR)	Operating Room (OR)
Input	Analog Video Input (BNC)NaviLink2D (Ethernet)	Analog Video Input (BNC)NaviLink2D (Ethernet)
Output	• 2D fluoroscopy image,• Augmented navigation information- Instrument- Screw (3D model)- Virtual Ruler	• 2D fluoroscopy image,• Augmented navigation information- Instrument- Screw (Cylinder)• C-arm position

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Item	Subject Device:Stryker Navigation System with SpineMap GoSoftware Application	Predicate Device:Stryker Navigation System – Spine andFluoroscopy System with Fluoroscopy 2.3Software (K012380)
User Interface	• Black-style graphical user interface• 16:9 screen ratio• One tab per task concept from left to right ontop of screen• Image toolbox for navigated tool visualization• Independent image adjustment options for eachview• Virtual keyboard• Mouse• IO Tablet with touch screen, USB ports, andCD/DVD drive• Buttons on Navigated Instruments	• Gray-style graphical user interface• 4:3 screen ratio• Movement between task conceptscontrolled by forward and back arrows.• Current task panel on the right• Image toolbar with image tools• Virtual keyboard• Mouse• IO Tablet with touch screen, USB ports,and CD/DVD drive• Buttons on Navigated Instruments
CameraWorkingSpace	1.25 m (meters)	1.25 m (meters)

6.7.2 Technological Comparison between the SpineMap Go Software and the Fluoroscopy 2.3 Software

The technological comparison between the subject device software (SpineMap Go software) and the predicate device is included in Table 6-4 below. The Fluoroscopy 2.3 software received 510(k) clearance per 510(k) number K012380.

Table 6-4: Technological Comparison between SpineMap Go software (Subject Device) and the Predicate Device Software

Item	Subject Device:SpineMap Go Software	Predicate Device:Fluoroscopy Software 2.3 (K012380)
Computer OperatingSystem	• Windows 8.1 (SPC 3.1)	• Windows XP Embedded (SPC 3.0 - StrykerPersonal Computer)• Windows 8.1 (SPC 3.1)• Off-the-Shelf Service Pack 3
Software Version	SpineMap Go 1.0-9/009	Virtual Fluoroscopy 2.3-7/009

6.7.3 Technological Comparison of the SpineMask Tracker, the Fluoroscopy Trackers, and Fluoroscopy Adapter with their Predicate Devices

The design of the SpineMask Tracker and the Fluoroscopy Trackers were updated to meet IEC 60601-1:2012 edition 3.1 and IEC 60601-1-2:2014 4th edition requirements. No changes were made to the design of the Fluoroscopy Adapters. In addition, the Indications for Use statements are being updated for the SpineMask Tracker and the Fluoroscopy Trackers and Fluoroscopy Adapters. The SpineMask Tracker's indications for use statement is being updated to allow it to be used with 2D spine navigation. The indications for use for the Fluoroscopy Trackers and the Fluoroscopy

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Adapters is being updated for clarification purposes only. No changes are being made to the performance or risk profile of these devices.

Summary of Non-Clinical Testing 6.8

The function and performance of the subject devices (Stryker Navigation 6.8.1 System with SpineMap Go software application, SpineMask Tracker, and Fluoroscopy Trackers and Fluoroscopy Adapters) have been evaluated through non-clinical design verification and validation testing. The results of the evaluation tests demonstrate that the subject devices successfully meet the requirements of their intended use.
6.8.2 Additional testing was performed on the subject devices to ensure the subject devices met their design requirements. A summary of the testing and the results are included in Table 6-5 below.

Item	Summary of Testing
Intended Use/ UserNeeds	The subject devices were validated with intended users in cadaverlabs or simulated use tests to ensure the user needs and intended userequirements were met. All requirements were met and no new issuesof safety or effectiveness were raised.
Accuracy	The system is designed to work in the working space with a meanaccuracy of 2 mm point and 2º angular axis displacement within theregistration zoneThe 95th percentile of the point displacement is ≤3 mm and ≤3° forangular axis displacement.
	Positionaldisplacement(mm) Trajectory AngleDisplacement(Degrees) Median 0.54 0.51 Interquartile Range 0.85 0.50 99th Percentile 2.17 2.09 Mean 0.68 0.56 Standard Deviation 0.59 0.37 99th ConfidenceInterval UpperBound 2.14 1.52
Safety	Verified the effectiveness of all risk controls determined in the devicerisk analysis. No new issues of safety or effectiveness were raised.
General Requirementsand Performance	Verified all components against their design specifications. Allrequirements were met and no new issues of safety or effectivenesswere raised.
Software	Software verification and validation testing was conducted as requiredby IEC 62304 and FDA guidance on general principles of softwarevalidation, January 11, 2002. All requirements were met and no newissues of safety or effectiveness were raised.
Electrical Safety	Verified conformance to IEC 60601-1:2012 Edition 3.1
ElectromagneticCompatibility	Verified conformance to IEC 60601-1-2:2014 Edition 4

Table 6-5: Summary of Non-clinical Testing

{13}------------------------------------------------

Summary of Clinical Testing 6.9

No clinical testing was performed.

6.10 Conclusion

The subject devices, Stryker Navigation System with SpineMap Go software application, SpineMask Tracker, Fluoroscopy Trackers and Fluoroscopy Adapters perform as intended and are substantially equivalent to their respective predicate device with respect to intended use, design, principles of operation, technology, materials, and performance. No new issues of safety or effectiveness have been raised.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).